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The objective of the study is to evaluate pain and disabling complications inducing social consequences in primary inguinal hernia ProGrip mesh repair compared to Lichtenstein repair with lightweight polypropylene mesh.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Parietex ProGrip |
|
| 2 | Active Comparator | Low weight polypropylene mesh |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parietex Progrip | Device | Surgical technique: Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Assessment During the First Three Months and at One Year After Surgery Using a Visual Analogue Scale (VAS) | Pain assessment during patient follow up after surgery using VAS score. VAS going from 0 mm (no pain) to 150 mm (worst conceivable pain) is presented to the patient who draw a vertical line on the scale to indicate the average amount of pain at the time of consultation or at home. | M3, M12 after surgery |
| Pain Assessment During the First Three Months and at One Year After Surgery Using a Surgical Pain Scales (SPS) | Surgical pain scales (=SPS) completed by patient during consultation or will be sent to the patient with instructions to complete it and send it back by mailing. The score of evaluation will be reported in mm, specifying if pain occurs at rest, during normal activities, during exercise. The score is ranged from 0 (no pain) to 150 mm (the worst pain yu have never known). | M3, M12 after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Foreign Body Sensation | Foreign body sensation using a specific questionnaire at M1, M3, M12 months after surgery. Questionnaire will be completed by patient during consultation or will be sent to the patient with instructions to complete it and send it back by mailing. | M1, M3, M12 months after surgery |
| Chronic Pain Defined as Pain Lasting More Than 3 Months Using VAS Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitaire Ziekenhuizen Leuven | Leuven | 3000 | Belgium | |||
| Klinikum Bremen-Mitte |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25146918 | Derived | Sanders DL, Nienhuijs S, Ziprin P, Miserez M, Gingell-Littlejohn M, Smeds S. Randomized clinical trial comparing self-gripping mesh with suture fixation of lightweight polypropylene mesh in open inguinal hernia repair. Br J Surg. 2014 Oct;101(11):1373-82; discussion 1382. doi: 10.1002/bjs.9598. Epub 2014 Aug 21. |
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Study period: 42 months First patient in: 13 October 2008 Last patient in: 27 April 2011 Last Patient visit: 8 May 2012 Follow-up duration: 1 year
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| ID | Title | Description |
|---|---|---|
| FG000 | Progrip Group | Parietex ProGrip Parietex Progrip : Surgical technique: Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation. |
| FG001 | Lichtenstein Group | Low weight polypropylene mesh Low weight polypropylene mesh : Surgical technique: Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Progrip Group | Parietex ProGrip Parietex Progrip : Surgical technique: Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation. |
| BG001 | Lichtenstein Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Foreign Body Sensation | Foreign body sensation using a specific questionnaire at M1, M3, M12 months after surgery. Questionnaire will be completed by patient during consultation or will be sent to the patient with instructions to complete it and send it back by mailing. | The analysis were performed on an As Treated population, with a 5% significance level. | Posted | Number | participants | M1, M3, M12 months after surgery |
|
12 months after surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Progrip Group | Parietex ProGrip Surgical technique: Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ischemic left testis | Reproductive system and breast disorders | Adverse event | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Seroma | Skin and subcutaneous tissue disorders | Adverse event | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pr. Andrew KINGSNORTH | Derriford Hospital, Department of Surgery | +44 175 276 3017 | Andrew.Kingsnorth@phnt.swest.nhs.uk |
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| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Low weight polypropylene mesh | Device | Surgical technique: Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures |
|
Chronic pain defined as pain lasting more than 3 months using VAS score. A VAS going from 0 mm (no pain) to 150 mm (worst conceivable pain) is presented to the patient who draw a vertical line on the scale to indicate the average amount of pain at the time of consultation or at home. |
| 3 months after surgery |
| Wound Complications and Hernia Recurrences | M12 after surgery |
| Return to Work and to Normal Daily Activities | Effective date |
| Other Post-operative Complications | M12 after surgery |
| Bremen |
| 28177 |
| Germany |
| Herz-Jesu-Krankenhaus gGmbH, Chirurgische Klinik | Fulda | D- 36039 Fulda | Germany |
| Catharina-ziekenhuis | Eindhoven | 5623 EJ | Netherlands |
| Medical Center Linköping | Linköping | 582 24 | Sweden |
| Centre of clinical research | Västeras- | 721 89 | Sweden |
| Western Infirmary | Glasgow | G11 6NT | United Kingdom |
| Imperial College London / Faculty of Medecine | London | W2 1NY | United Kingdom |
| Derriford Hospital | Plymouth | PL6 | United Kingdom |
Low weight polypropylene mesh
Low weight polypropylene mesh : Surgical technique:
Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures
| BG002 | Total | Total of all reporting groups |
| years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Low weight polypropylene mesh
Low weight polypropylene mesh : Surgical technique:
Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures
|
|
| Secondary | Chronic Pain Defined as Pain Lasting More Than 3 Months Using VAS Score | Chronic pain defined as pain lasting more than 3 months using VAS score. A VAS going from 0 mm (no pain) to 150 mm (worst conceivable pain) is presented to the patient who draw a vertical line on the scale to indicate the average amount of pain at the time of consultation or at home. | Posted | Number | participants | 3 months after surgery |
|
|
|
| Primary | Pain Assessment During the First Three Months and at One Year After Surgery Using a Visual Analogue Scale (VAS) | Pain assessment during patient follow up after surgery using VAS score. VAS going from 0 mm (no pain) to 150 mm (worst conceivable pain) is presented to the patient who draw a vertical line on the scale to indicate the average amount of pain at the time of consultation or at home. | The analysis were performed on an As Treated (AT)population, with a 5% significance level. | Posted | Mean | Standard Deviation | units on a scale | M3, M12 after surgery |
|
|
|
| Primary | Pain Assessment During the First Three Months and at One Year After Surgery Using a Surgical Pain Scales (SPS) | Surgical pain scales (=SPS) completed by patient during consultation or will be sent to the patient with instructions to complete it and send it back by mailing. The score of evaluation will be reported in mm, specifying if pain occurs at rest, during normal activities, during exercise. The score is ranged from 0 (no pain) to 150 mm (the worst pain yu have never known). | The analysis were performed on an As Treated population (AT), with a 5% significance level. | Posted | Mean | Standard Deviation | units on a scale | M3, M12 after surgery |
|
|
|
| Secondary | Wound Complications and Hernia Recurrences | The analysis were performed on an As Treated (AT) population, with a 5% significance level. | Posted | Number | participants | M12 after surgery |
|
|
|
| Secondary | Return to Work and to Normal Daily Activities | The analysis were performed on an As Treated (AT) population, with a 5% significance level. | Posted | Mean | Standard Error | days | Effective date |
|
|
|
| Secondary | Other Post-operative Complications | As Treated population | Posted | Number | participants | M12 after surgery |
|
|
|
| 18 |
| 304 |
| 23 |
| 304 |
| EG001 | Lichtenstein Group | Low weight polypropylene mesh Surgical technique: Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures | 21 | 299 | 29 | 299 |
| High pain just after surgery, ilioinguinal nerve trapped in suture | General disorders | Adverse event | Systematic Assessment |
|
| Inguinal hernia recurrence | Surgical and medical procedures | Adverse event | Systematic Assessment |
|
| Right Total Hip Replacement | Surgical and medical procedures | Adverse event | Systematic Assessment |
|
| inguinal pain after lifting a heavy weight, suspected hernia recurrence | General disorders | Adverse event | Systematic Assessment |
|
| Acute retention of urine | Renal and urinary disorders | Adverse event | Systematic Assessment |
|
| prostate adenocarcinoma | Renal and urinary disorders | Adverse event | Systematic Assessment |
|
| Hand Tendon Injury | Injury, poisoning and procedural complications | Adverse event | Systematic Assessment |
|
| Ureter transection left, direct suture | Renal and urinary disorders | Adverse event | Systematic Assessment |
|
| Melena red blood loss per anum Hospitalisation | Blood and lymphatic system disorders | Adverse event | Systematic Assessment |
|
| Pulmonary sarcoïdosis | Respiratory, thoracic and mediastinal disorders | Adverse event | Systematic Assessment |
|
| atrial flutter | Vascular disorders | Adverse event | Systematic Assessment |
|
| Atrial fibrillation | Vascular disorders | Adverse event | Systematic Assessment |
|
| lungmetastasis dorsolateral right lung | Respiratory, thoracic and mediastinal disorders | Adverse event | Systematic Assessment |
|
| necrotic defect 0,5cm scar pace maker | Cardiac disorders | Adverse event | Systematic Assessment |
|
| Lung Embol | Respiratory, thoracic and mediastinal disorders | Adverse event | Systematic Assessment |
|
| Elective trans-urethral resection of prostate | Reproductive system and breast disorders | Adverse event | Systematic Assessment |
|
| edema, poor kidney function, decompensation cordes, pneumonia | General disorders | Adverse event | Systematic Assessment |
|
| enlarged prostate gland resulting in surgical intervention | Reproductive system and breast disorders | Adverse event | Systematic Assessment |
|
| HERNIA RECURRENCE ADMISSION FOR REPAIR | Surgical and medical procedures | Adverse event | Systematic Assessment |
|
| NEURALGIC PAIN RIGHT GROIN (post-op) | General disorders | Adverse event | Systematic Assessment |
|
| hospitalization surgery umbilical hernia | Surgical and medical procedures | Adverse event | Systematic Assessment |
|
| Cancer colon + metastasis liver and spleen | Gastrointestinal disorders | Adverse event | Systematic Assessment |
|
| Wound infection | Infections and infestations | Adverse event | Systematic Assessment |
|
| Hematoma | Skin and subcutaneous tissue disorders | Adverse event | Systematic Assessment |
|
| Increasing pain in the inguinal area | General disorders | Adverse event | Systematic Assessment |
|
| Gastric Ulcus Perforation | Gastrointestinal disorders | Adverse event | Systematic Assessment |
|
| neuronitis vestibularis left | Eye disorders | Adverse event | Systematic Assessment |
|
| acute on chronic renal insufficiency | Renal and urinary disorders | Adverse event | Systematic Assessment |
|
| Hematoma | Skin and subcutaneous tissue disorders | Adverse event | Systematic Assessment |
|
| Site Surgical Infection | Skin and subcutaneous tissue disorders | Adverse event | Systematic Assessment |
|
| Recurrence | Skin and subcutaneous tissue disorders | Adverse event | Systematic Assessment |
|
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| Site Surgical Infection |
|
| Recurrence |
|